Hypodermic ampoules



June 25, 1963 R. P. DUNMIRE HYPODERMIC AMPOULES 3 Sheets-Sheet 1 Filed Sept. 18, 1961 Inna,

III

INVENTOR.

RUSSELL F? DUN/WIRE DECEASED, by

Hannah Dunmire, Executrix [III] A fforneys June 25, 1963 R. P. DUNMIRE 3,094,987

HYPODERMIC AMPOULES Filed Sept. 18, 1961 3 Sheets-Sheet 2 INV EN TOR.

RUSSELL I? DUN/WIRE,

DECEASED, by Hannah Dunmire,Execufrfx Attorneys June 25, 1963 R. P. DUNMIRE HYPODERMIC AMPOULES 3 Sheets-Sheet 3 Filed Sept. 18, 1961 INVENTOR.

RUSSELL I? DUN/WIRE DECEASED, by Hannah Dunmire, Exe ufrix BYg Afforneys nited States Patent 9 3,04,987 HYPODERNHC OULES Russell P. Dunmire, deceased, late of Chagrin Falls, Ohio, by Hannah Dunmire, executrix, 29550 Pike Drive, Chagrin Falls, Ohio Filed Sept. 18, 1961, Ser. No. 138,999 23 Claims. ((Zl. 128-216) This invention relates generally to hypodermic injection devices, and more specifically to improvements in disposable hypodermic ampoules of the type disclosed in my U.S. Patents 2,696,212 and 2,769,443, granted December 7, 1954 and November 6, 1956, respectively.

As disclosed in the above-identified patents, the basic construction of my hypodermic ampoule or syringe preferably comprises a body having the general form of an inverted, cup-shaped shell which defines a reservoir for containing a prescribed volume of hypodermic liquid. The hypodermic liquid is confined within the reservoir by a generally flat, lower end wall or diaphragm which extends across the mouth of the shell and is sealed to its periphery. Contained entirely within the sealed ampoule body is a hypodermic needle disposed in axial alignment with the body with the pointed end of the needle extending toward, but terminating short of the flat, lower end wall or diaphragm. The butt end of the needle is secured adjacent the inner, upper end wall surface of the inverted cupshaped shell, and an opening into the butt end of the needle is exposed to the hypodermic liquid so that the liquid can flow freely into and through the needle during the administration of an injection.

In use, the ampoule is positioned with the diaphragm against the skin and pressure is applied to the upper end wall of the ampoule to collapse it axially inwardly. When collapsing pressure is applied, the sharp end of the hypodermic needle is forced downwardly to pierce the diaphragm. Further pressure results in the needle penetrating the skin and the ampoule body being collapsed to evacuate the hypodermic liquid through the needle.

In order to assure a safe, reliable, and practical manner of administering a hypodermic injection, devices of the type described must satisfy two basic requirements which have been established by the medical profession and U8. Government agencies. The first of these requirements is that the ampoule must be capable of discharging in excess of 90% of the contained hypodermic liquid. The pri mary reason for this requirement is, of course, to assure that an accurate dosage can be administered with each ampoule. A maximum discharge from the ampoule also is important from the standpoint of preventing waste of the hypodermic liquid.

The second basic requirement of hypodermic ampoules is that the minimum evacuation of 90% can be obtained by a manually applied force of not more than 10 or 12 pounds. If a greater force is required to collapse the ampoule and effect the injection, the danger exists that the user will discontinue the injection before the full dosage has been administered.

While the hypodermic ampoules disclosed in my aboveidentified patents have been successfully used in many applications, there has been found a need for certain improvements in their construction in order to completely satisfy the aforementioned requirements.

Accordingly, it is a general object of the present invention to provide improvements in disposable, hypodermic ampoules of the type heretofore described.

A more specific object of the invention is to provide a new and improved ampoule body construction which facilitates a safe, efiicient, and practical selfadministration of hypodermic injections by relatively unskilled and untrained persons.

Another object of the invention is to provide an im- 2 proved body construction for a hypodermic ampoule which is capable of discharging at least of the contained hypodermic solution when subjected to a collapsing tor-cc of not more than 10 or 12 pounds.

The foregoing objects and advantages of the invention have been attained by constructing the cup-shaped ampoule body so that, when axial pressure is applied to the upper end wall of .the ampoule, it will telescopic-ally collapse with what may be termed a partial inverting action in which approximately the upper half of the body is turned inside-out and nested within the lower part, sub stantially filling the same. According to the preferred forms of the invention, a roll-type collapsing action occurs in which the side wall of the body initially folds at a predetermined circumferential location and then rolls on itself in the direction of the applied axial pressure to progressively turn inside-out until the upper end wall is seated against the diaphragm. As will hereinafter become more apparent, these characteristic features of the invention assure that substantially all of the hypodermic liquid will have been discharged when the upper end wall of the ampoule is pressed against the diaphragm and that only the minimum applied force is required to effect the injection.

In terms of structure, the ampoule body construction contemplated by the invention is comprised of a rigid upper end wall that merges into an at least partially conical, outwardly and downwardly flaring side wall. The side wall includes an upper flexible portion and a lower portion of larger diameter that is relatively more rigid and inflexible.

In the presently preferred embodiment of the invention, the upper and lower portions of the side wall are integrally connected to define the location of a primary hinge about which the upper part of the side wall folds downwardly under applied pressure to initiate collapsing thereof by a progressive rolling or shifting of the fold toward the upper end wall until the entire top section of the body has moved downwardly within the bottom section while the top section is being inverted.

The relative dimensions of the top and bottom sections of the body are controlled in relation to the volume of the ampoule so that, when it has been collapsed, the side wall portion of the inverted top section of the body is disposed closely adjacent the inner side wall surface of its bottom section and the upper rigid end wall of the ampoule is seated against the diaphragm. This collapsed configuration of the :ampoule provides for a controlled evacuation of the hypodermic liquid well in excess of 90%. Further, the preferred type of axial folding and progressive rolling collapse of the upper side wall as the top section of the body is inverted and moved within the bottom section enables the resulting high evacuation normally to be obtained with an applied force of only 4 or 5 pounds.

The improved ampoule contemplated by the invention also is desirably constructed to minimize any tendency of the ampoule to aspirate the injected hypodermic liquid and/ or natural body fluid back into the body after the injection has been made. This is preferably accomplished by providing a special hinge action around the upper end wall of the ampoule where it merges with the side wall. When'the ampoule has been collapsed, the hinge at this location acts to lock the upper end wall tightly against the diaphragm and prevent the am-poule body from elastically expanding back toward its original shape and thereby creating a vacuum which would cause liquid to be sucked back into the body through the needle.

Other objects and advantages of the invention will become apparent from the following detailed description of several illustrative embodiments and from the accompanying drawings.

'In the drawings:

FIGURE 1 is a vertical, cross sectional view of a hypodermic ampoule embodying the presently preferred shell construction of the present invention;

FIGURESZ and 3 are vertical cross-sectional views of the ampoule of FIG. 1 which illustrate successive stages in its evacuation;

FIGURE 4 is another vertical, cross-sectional view of the ampoule of FIG. 1 which illustrates its configuration after the injection has been completed;

FIGURE 5 is a top plan view of the ampoule of FIG. 1;

FIGURE 6 is a fragmentary cross-sectional view of a portion of the body of the ampoule of FIG. 1;

FIGURE 7 is a vertical cross-sectional View of a modified embodiment of the invention; and

FIGURE 8 is a vertical cross-sectional view of still another modified embodiment of the invention.

Reference is first made to FIG. 1 which illustrates a disposable hypodermic ampoule shell including a body 11 constructed according to the present invention. As shown, the body 11 is generally in the form of an inverted cup. What would be the bottom of the cup defines the upper end wall 16 of the body. The open end or mouth of the body 11 is closed by a diaphragm 13 to form a reservoir for containing a hypodermic liquid 12 (shown only in FIG. 1).

Entirely enclosed within the ampoule shell is a hypodermic needle 14 which preferably is of the type disclosed in the copending application of R. P. Dunmire et al., Ser. No. 158,944, filed December 8, 1961. The illustrated circular base or but-t end 15 of the needle 14 is mounted adjacent the upper end wall of the ampoule body 11 so that the needle is in substantial axial alignment with the body and has its pointed end 17 projecting downwardly in position to be forced through the diaphragm 13. A cannula opening (not shown) through the base 15 of the needle permits the hypodermic liquid 12 to be evacuated from the ampoule shell through the hypodermic needle after it has pierced the diaphragm.

As more specifically described in my copending application, Ser. No. 139,000, filed September 18, 1961, the diaphragm 13 is constructed to avoid 'a rapid build-up of hydraulic pressure within the liquid-filled shell and a consequent hydraulic lock which could result in the ampoule body being ruptured before the hypodermic needle can be forced through the diaphragm at the initiation of an injection. Provision is also made to guide the hypodermic needle for entry into the skin in a direction substantially perpendicular thereto and to prevent an undersirable loss of the hypodermic liquid 14 during an injection as by leakage around the outside of the needle where it pierces the diaphragm. To these ends, the diaphragm 13 has an outer annular portion 24, a thick, elongated, centrally located needle guiding and liquid sealing gland 25 and a relatively thin, flexible, corrugated intermediate portion 26' connecting the gland and outer portion to permit relative movement therebetween. An axial needle passage 27 extends into the upper end of the gland from inside the ampoule shell and terminates short of the opposite, lower end of the gland to form a thin, easily puncturable wall 29 closing the bottom of the passage. A portion of the needle 14 is slidably constrained within the passage with an interference fit and with the tip 28 of the needle normally spaced from the puncturable wall 29.

Due to the stiflness of the gland 25 and the length over which it contacts the needle, an effective peripheral liquid seal is maintained around the needle under the hydraulic pressure created during discharge of the ampoule. At the same time, the gland 25 is effective to support and pilot the needle during an injection. This guided movement of the needle minimizes the possibility of its being cocked and inserted at an oblique angle to thereby tear the skin and/or tail to penetrate to the required depth for an effective injection.

The thin, flexible, corrugated wall section 26 of the diaphragm 13 permits the gland 25 to move relative to the outer diaphragm portion 24 axially inwardly of the ampoule shell when the diaphragm is initially pressed against the skin. Because of this movement of the gland, the distance through which the hypodermic needle 14 must travel before it pierces the diaphragm wall 29 and relieves the hydraulic pressure Within the shell is relatively small. To the extent that inward movement of the gland 25tends to reduce the interior volume of the liquid filled shell, the: corrugated wall section 26 of the diaphragm is capable of bulging outwardly momentarily until the needle has punctured the diaphragm and provided an escape path through the needle for the liquid. Consequently, it is possible to provide suflicient clearance between the tip 28 of the needle and the gland wall portion 29 to avoid accidental puncturing of the diaphragm during handling of the ampoule, and, at the same time, to prevent the creation of a hydraulic lock atthe start of an injection.

The diaphragm '13 is further shown to include a stiif, annular rib 30 integrally extending from the" upper surface of the outer diaphragm portion 24. This rib 3b is formed on a diameter such that it may be tightly nested within the mouth of the ampoule body against its inner wall surface. During filling and assembly of the ampoule shell, the rib 30 aids in locating the diaphragm 13 with respect to the body ll so that the end 17 of the needle 14 will be aligned with and accurately inserted within the needle passage '27 of the gland 25. The rib 30 also forms a temporary liquid'seal for preventing the hypodermic liquid from spilling from the mouth of the ampoule body 11 prior to the diaphragm and body being permanently sealed together around their peripheries.

In use, the ampoule shell is positioned with the diaphragm 13 against the skin and a radially inwardly directed pressure is applied 'to the upper end wall 16, either manually with the thumb or by means of a mechanical applicator as may be desired. The initial application of pressure to the upper end wall force's' the gland 25 inwardly relative to the body 11 and causes the tip 28 of the needle to penetrate the relatively thin gland wall 29.

. Continued application of pressure results in the hypodermic needle being inserted into the skin and the body 11 being collapsed, in the manner to be more specifically described, so as to discharge substantially all of the hypodermic liquid through the needle.

As shown most'clearly in FIGS. 1 and 5, the inverted cup-shaped configuration of the ampoule body 11 is formed by the generally circular upper end wall 16 and byan integral, circumferentially extending side wall. An annular, radially inwardly directed rib 34 is preferably formed within the body 11 in spaced relation to the inner surface of its upper end wall l6 for the purpose of forming a socket and clamping'ly holding the needle base 15 in the socket to secure the needle 14 in a fixed position within the ampoule. The side wall of the body 11 also haslan outwardly directed flange 35 integrally extending around the lower periphery thereof, and the relatively flat diaphragm 13 is joined to this peripheral flange to form a moisture proof seal.

The entire ampoule shell, including the body 11 and the diaphragm 13, may be made of any stifliy flexible material which is inert and retains its strength when exposed to the hypodermic liquid, and which will not rupture and/or tear as the ampoule is collapsed. Suitable materials include tough, but relatively flexible elastomeric compounds, including plastics such as polyethylene and various polyvinyl compounds and the like; plastic coated metal foils; and uncoated metal foils which may be joined to form a leakproof liquid seal.

When, as in the preferred embodiment of the invention, the ampoule shell is made of plastic and the body 11 and diaphragm 13 are joined by heat-sealing, the circum ferential flange 35 is preferably formed with an annular groove in which is seated a metal ring 36. As more fully explained in my copending application Serial No. 252,272, filed January 15, 1963, the metal ring 36 facilitates a quick and localized application of heat to effect the heatsealing of the mating flanges and thereby prevent the possibility of the hypodermic liquid being deleteriously effected by the heat and/ or the material of the ampoule being structurally weakened.

As generally discussed above, the side wall of the body 11 is preferably comprised of a flexible upper portion 37 and a lower portion 38 of larger diameter that is relatively more rigid and inflexible. In the preferred embodiment of the invention illustrated in FIGS. 1-6, the upper side wall portion 37 is conical with a slight outward and downward inclination from the upper end wall 16, while the lower side wall portion 38 is substantially cylindrical. The upper and lower portions of the side wall are integrally joined by a relatively flexible zone in the form of a short, thin, circumferential shoulder 39.

As shown, the relative wall thicknesses of the side wall of the preferred embodiment of the ampoule body 11 are such that, when axially directed pressure is applied, the relatively rigid and inflexible lower portion 38 will remain substantially undistorted and the more flexible upper portion 37 will fold and progressively roll on itself until the top section of the body, designated T in FIG. 1, is inverted within the confines of the bottom section, designated B. To this end, the upper portion 37 of the side wall is made as thin as possible to permit an easy folding and rolling action and still retain sufficient strength to resist fracture or bursting and tearing. It is also preferred to taper this portion of the side wall from a maximum thickness at its upper end to a minimum thickness at its lower end.

The lower portion 38 of the side wall of the ampoule body may have a thickness approximately twice the maximum thickness of the upper side wall portion. The shoulder 39 between the two upper and lower portions is no thicker and is preferably slightly thinner than the minimum thickness of the upper side wall portion so as to define a primary hinge at which collapsing of the side wall is controllably initiated.

The combined thicknesses of the body flange 35 and diaphragm 13, the thickness of the annular portion 24 of the diaphragm around the corrugated portion 26, and the thickness of the opposed upper end wall 16 of the body are all sufficiently great to eliminate any significant distortion ofthe ampoule shell in these zones when a collapsing pressure is applied to the ampoule.

In order to accomplish the objective of obtaining the maximum discharge of substantially all of the hypodermic liquid contained in the ampoule, it has been found necessary, in the body construction described, to maintain a ratio between the height X (FIG. 1) of the lower side wall portion 3-8 and the total height Y of the side wall of the body which will permit the upper end wall 16 of the body to bottom against the diaphragm 13 and the upper side wall portion 37 to turn inside-out and lie closely adjacent the inner surface of the lower side wall portion 38. If this ratio is too small and the height X of the lower side wall portion 38 is substantially less than the height Z of the upper portion 37, the upper portion will not lie against the inside surface of the lower portion'when the ampoule body is collapsed. Conversely, if the ratio of the height X of the lower portion to the total height Y of the side wall is too large, the upper end wall of the body will not be able to bottom against the diaphragm 13. The optimum height ratio of the lower portion of the side wall to the total side wall depends upon the volume of the ampoule, the material of which the body 11 is made, the relative wall thicknesses, the length of the shoulder 39, and other design details and will vary accordingly. However, in the particular embodiment illustrated in FIGS.

1-6, it has been found that the height X of the lower wall portion 38 should exceed the height Z of the upper wall portion 37 and preferably should be in the range of from 50 to 60% of the total side wall height Y.

Referring particularly to FIG. 6, it will be seen that the ampoule body is further provided with a circumferential zone formed as a notch or groove 40 adjacent the upper end wall 16. As will be more fully explained, this notch 44) defines the location of a secondary hinge which permits the top body section T of the shell to be inverted and nested within the bottom section B with the upper end wall of the body locked against the diaphragm.

Reference is now made to FIGS. 2, 3 and 4 which illustrate progressive stages in the collapsing of the ampoule body. It will be seen in FIG. 2, that when pressure is applied to the upper end wall 16, as by pressing with the thumb, the shoulder 39 defines the initial location of a primary hinge about which the side wall is folded to initiate collapsing thereof. Continued application of pressure forces the flexible upper side wall portion 37 to progressively roll downwardly on itself until it is substantially turned inside out and telescoped within the bottom section 38, as illustrated in FIG. 3.

With still continued application of pressure, the secondary hinge at the notch 40 is closed and the top shell section T is turned completely inside-out and inverted, with the end wall 16 bottomed against the diaphragm 13 within the annular rib 30 (FIG. 4).

Taking FIGS. 3 and 4 in conjunction, it will be seen that bending at the secondary hinge by closing of the notch 40' has the elfect of partially relieving the reverse bend 41 (FIG. 3) momentarily formed in the side wall of the body around the upper end wall 16 by the final stage of downward collapsing movement of the upper side wall portion. As this reverse bend 41 is relieved, the secondary hinge defined by the notch 40 bends through and beyond a dead center position so that the body section T is completely turned inside-out and elastic stresses tending to turn it toward its original shape are relieved. In fact, the action of passing through a dead center position at the location of the secondary hinge as the secondary hinge is closed provides a locking action by which an elastic force is created that urges the upper end wall 16 downwardly against the diaphragm 13. The elasticity of the ampoule body 11 is thereby utilized to resist return toward its original shape. Thus, it will be seen that the provision of the secondary hinge minimizes the possibility of aspiration, since there is little chance for a vacuum to form in the ampoule body after the hypodermic liquid has been evacuated.

The relative heights of the upper and lower portions of the side wall are carefully controlled, as previously discussed, so that, when the top section T of the shell has been completely inverted by closing of the secondary hinge notch 40, the upper end wall 16 is seated against the diaphragm 13 (FIG. 4), and the resulting configuration of the collapsed ampoule shell resembles one cup nested within another. This collapsed form of the ampoule shell assures that at least and usually from to 97%, of the hypodermic liquid will have been discharged during the injection.

The unique rolling action by which the side wall of the ampoule body initially folds about the primary hinge 39' and the flexible upper side wall portion 38 progressively rolls downwardly upon itself and turns inside-out against the inner surface of the lower portion 38 requires a relatively small force to be applied to the ampoule. In most instances, a force of 4 or 5 pounds, or approximately the force exerted by a firm handshake, is sufficient. The rolling, collapsing action by which the ampoule body is collapsed acts in conjunction with the previously described gland 25 to provide the additional advantage of preventing the needle from cocking as it is thrust through the diaphragm 13 intothe skin.

Reference is now made to FIG. 7 which illustrates a r modified embodiment of the hypodermic ampoule body construction comprising the present invention. As in the case of the preferred embodiment of FIGS. 16, the ampoule generally includes a body 50 in the form of an inverted cup that is defined by an upper end wall 51 and a circumferentially extending side wall. A diaphragm 52, which generally corresponds to the previously described diaphragm 13, extends across the mouth of the cup-shaped body 50 and is sealed to the peripheral flange 53. Reference numeral 54 designates a metal heat sealing ring between the diaphragm 52 and the flange 53.

For purposes to be more fully explained, the annular rib 55', which integrally extends from the upper surface of the diaphragm 52 into the mouth of the ampoule body, may be made of greater height than the previously described rib 30 of the diaphragm 13 shown in FIGS. 1-4. As is apparent from FIG. 7, when the rib '55 is pressed into the mouth of the ampoule body 50, the rib engages a substantial portion of the inner side wall surface of the body to effectively thicken and strengthen that portion of the side wall. In this assembled position of the diaphragm 52, the rib 55 may be thus considered as forming part of the lower portion of the circumferential, ampoule body side wall and the radially inward, sloping surface 56 of the rib may be considered, in effect, as being a lower, inner side wall surface of the ampoule body.

A hypodermic needle 57 (only a portion of which has been shown for the sake of clarity) corresponds to the needle 14 in FIGS. 1-4 and is similarly mounted within the body 50 by an integral, radially inwardly extending rib 58. The opposite, pointed end portion (not shown) of the needle is slidably constrained within the gland 59' in the manner previously described in connection with the structure of FIGS. 14.

In the modified body construction of FIG. 7, the entire circumferentially extending side wall (excluding the functionally integral rib 55 of the diaphragm) is conical and has an outward and downward inclination from the upper end wall 51. The thickness of the side wall substantially uniformly tapers from a minimum thickness at the upper end wall 51 to maximum thickness at the mouth of the ampoule body.

In order to provide for the desired collapsing action of the body 50, wherein an upper portion of the side wall is caused to progressively roll on itself and turn insideout against the inner surface of a lower part of the ampoule, the top of the ampoule body is formed with an external, circumferential notch 60. This notch 60 defines a thin, flexible shoulder 61 at the upper end of the circumferentially extending side wall of the ampoule body. The shoulder 61 is no thicker and is preferably slightly thinner than the minimum thickness of the tapering side wall and thus constitutes the primary hinge at which collapsing of the side wall is controllably initiated.

A second circumferential notch or groove 62 is formed in the outside surface of the side wall of the ampoule body 50 between the top and the bottom of the side wall. The side wall thickness of the ampoule body at the notch 62 is slightly greater than the thickness of the shoulder 61 so as to form a secondary hinge that aids in locking the upper end wall 51 against the diaphragm 52 after the ampoule body has been collapsed.

The notch 62 divides the ampoule body int-o a top section T and a bottom section B which are respectively defined by an upper portion 63 of the circumferentially extending side wall and a lower portion 64 of the side wall. Inasmuch as the ampoule side wall is generally conical and has a tapering thickness decreasing from its top to its bottom, the upper side wall portion 63 is relatively flexible, and the lower side wall portion 64, which is further reinforced by the functionally integral rib 55 of the diaphragm, is relatively more rigid and inflexible and has a larger diameter. These relative wall thicknesses are such that the upper side wall portion 63 will roll on itself when axially directed pressure is applied to the ampoule body, while the lower side wall portion 64 will remain substantially undistorted.

As in the case of the previously described, preferred embodiment of the invention, the relative heights X and Z of the upper and lower side wall portions 63 and 64, respectively, are carefully controlled to assure that substantially all of the hypodermic liquid 12 can be discharged by collapsing the ampoule body. More particularly, the ratio of the height X of the lower side wall portion 64 to the total height Y of the ampoule body is such that the upper end wall 51 will seat against the diaphragm 52 and the upper side wall portion 63 will lie against the radially inner surface 56 of the diaphragm rib when the ampoule is collapsed.

The progressive stages of deformation of the ampoule body 50 as it is collapsed are schematically indicated by dot-dash lines in FIG. 7. After pressure has been initially applied to the upper end wall 51 to start penetrating movement of the hypodermic needle 57 through the diaphragm 52, the shoulder 61, which constitutes the primary hinge in this embodiment, is folded or bent downwardly to initiate collapsing of the circumferential side wall. Thereupon, the relatively flexible upper side wall portion 63 is caused to progressively roll downwardly on itself toward the notch 62, 'as indicated by the upper dotdash lines in FIG. 7, until the upper side wall portion 63 is substantially turned inside-out, as indicated by the lower dot-dash lines in FIG. 7.

In the last stage of collapsing movement, the upper end wall 51 is forced against the diaphragm 52 to completely and telescopically invert the top body section T within the bottom body section B with the flexible upper side wall portion 63 disposed against the inner surface 56 of the diaphragm rib '55. The illustrated construction of the rib 55, wherein its radially inner surface 56 slopes axially inwardly of the ampoule body from the notch 62' toward the mouth of the body is of advantage since it assures maximum evacuation of the hypodermic liquid by filling the space between the inverted wall portion 63 and the lower wall portion 64 and thus preventing liquid from being trapped therebetween. However, it will be apparent that this same effect could be achieved by forming the body section B so that its lower side wall portion 64 has an axially inwardly and downwardly sloping inner (surface.

As the ampoule body is finally collapsed, the secondary hinge at the notch 62 opens up to minimize elastic stresses in the folded part of the side wall that would tend to cause the side wall to unfold and the ampoule body to return toward its original shape.

In addition to defining the location of the primary hinge 61, the notch acts similarly to the notch 40 previously described in conjunction with the preferred embodiment of the invention by providing a locking action wherein the upper end wall 51 is urged against the diaphragm 52 when the ampoule has been finally collapsed. When the shoulder 61 is folded downwardly to initiate collapsing of the side wall of the ampoule body, the notch 60 is closed and the shoulder 61 is bent through a dead center position. This movement of the shoulder through a dead center position effectively creates an elastic force in the material of the shoulder that urges the upper end wall 51 downwardly so that, when the notch 62 has been opened to relieve oppositely acting stresses in the fold of the side wall, the upper end wall will be effectively locked against the diaphragm and prevented from returning toward its original position.

Reference is next made to FIG. 8 which illustrates still another embodiment of the invention. The body of the ampoule is again substantially in the form of an inverted cup including an upper end wall 71 and a circumferentially extending side wall. Reference numeral 72 designates a diaphragm that corresponds in structure to the diaphragm 13 illustrated in FIGS. 1-4 and similarly extends across the mouth of the body and is sealed to a peripheral flange 73. The metal heat sealing ring is shown at 74.

A hypodermic needle 75 (only a portion of which has been shown for the sake of clarity) is disposed entirely within the ampoule body in axial alignment therewith. The base of the needle is clipped adjacent the upper end wall 71 of the body by a radially inwardly extending rib 76, and the opposite, pointed end portion (not shown) of the needle is slidably constrained within the gland 77 in the manner previously described in connection with the structure of FIGS. 1-4.

As in the case of the embodiment illustrated in FIG. 7, the ampoule body 70 is formed with an external, circumferential notch or groove 83 at the upper end of the side wall. This notch 83 defines a relatively thin and flexible shoulder 84 which is no thicker and is preferably slightly thinner than the minimum thickness of the side wall and thus constitutes a primary hinge at which collapsing of the side wall is controllably initiated.

A second circumferential notch or groove 85 is formed in the inner side wall surface of the ampoule body between the upper end wall 71 and the mouth of the body. This notch 85 divides the ampoule body into a top body section T that is defined by a relatively flexible upper side wall portion 86 and a bottom body section B that is defined by a relatively inflexible and rigid lower side wall portion 87. The side wall thickness at the notch 85 may be slightly thicker than the shoulder 84 so as to form a secondary hinge which aids in locking the upper end wall 71 against the diaphragm 72 by relieving elastic stresses created in the side wall.

The flexible upper side wall portion 86 is conical with an outward and downward inclination from the upper end wall 71 and has a wall thickness that preferably tapers from a minimum thickness at the notch 83 to a maximum thickness just above the notch 85. The relatively inflexible and more rigid lower side wall portion 87 may be substantially cylindrical and is formed to have an inner side wall surface 89 that slopes axially inwardly of the ampoule body from the notch 85 toward the mouth of the body. This sloping inner surface 89 of the side wall portion 87 provides the same beneficial effect as the rib construction 55 shown in FIG. 7 by preventing hypodermic liquid f-rom being trapped in the ampoule body when it has been collapsed. The relative side wall thicknesses of the ampoule body are such that the upper side wall portion 86 can be rollingly turned inside-out when axial pressure is applied to the ampoule, while the lower side wall portion 87 will remain substantially undistorted.

In accordance with the previously described embodiments of FIGS. 1-6 and FIG. 7, the relative heights X and Z of the upper and lower side wall portions 86 and 87, respectively, are controlled to achieve maximum discharge of the hypodermic liquid. To this end, the location of the notch 85 is such that the ratio of the height X to the total height Y of the side wall will permit the upper end wall 71 to be seated against the diaphragm and the inverted upper side wall portion 86 to lie against the sloping inner surface 89 of the lower side wall portion.

The collapsing action of the ampoule 70 is generally similar to that discussed in connection with the structure of FIG. 7 and is schematically indicated in FIG. 8 by the dot-dash lines. After pressure has been initially applied to start penetrating movement of the needle 75 through the gland 77 of the diaphragm, the shoulder 84, which constitutes the primary hinge in this embodiment, is bent downwardly to initiate folding and collapsing of the side wall. During this initial bending movement, the notch 83 is closed and the shoulder 84 is moved through a dead center position. An elastic force is thereby created in the material of the shoulder and this elastic toreetends to further urge the upper end wall 71 toward the diaphragm 72.

- 10 v Continued axial pressure on the ampoule causes the relatively flexible upper side wall portion 86 to progressively roll inside-out, as indicated by the upper dot-dash lines in FIG. 8, and the fold in the upper side wall portion to move toward the notch 85. In this particular embodiment of the invention, the upper side wall portion 86 may bow or flex outwardly a slight amount as it is rolled downwardly; however, the characteristic ease with which the upper side wall portion may be inverted is not significantly different from that exhibited by the other embodiments of the invention.

In the final stage of collapsing movement, the upper end wall 71 is seated against the diaphragm 72 and the top body section T is completely telescopically inverted within the bottom body section B with the flexible side wall portion 86 against the inner surface 89 of the lower side wall portion 87. As this position is reached, the notch is closed to locate the downward bend or fold of the side wall. As noted above, this minimizes the elastic stresses in the folded part of the side wall and thus the tendency of the side wall to unfold and the ampoule body to return toward its original shape.

As in the preferred embodiment of the invention, it will be seen that the modified embodiments of FIGS. 7 and 8 provide for the unique rolling action by which an upper portion of the side wall of the ampoule body is caused to roll downwardly as the ampoule is collapsed and to turn inside-out against the inner surface of a lower side wall portion. This rolling and inverting action has been achieved by the provision of primary and secondary hinges which enable the ampoules to be controllably collapsed by a relatively small axial force. At the same time, the modified ampoule body constructions assure that very nearly all of the hypodermic liquid can be discharged during an injection.

Many additional modifications and variations of the invention will obviously be apparent to those skilled in the art in view of the foregoing detailed disclosure. Therefore, it is to be understood that, within the scope of the appended claims, the invention may be practiced otherwise than as specifically shown and described.

What is claimed is:

1. In a hypodermic ampoule device including a generally cup-shaped body defined by an upper end wall and a circumferentially extending side wall, a diaphragm peripherally sealed to said body across its mouth to form a lower end wall, and a hypodermic needle secured within said body in position to be thrust through said diaphragm by collapsing of said body; an improved body construc tion comprising a top section and an integrally connected bottom section of greater diameter than said top section; said top section of said body being defined by an upper side wall portion, said upper side wall portion being relatively flexible for progressively bending and rolling on itself from one end to the opposite end thereof and thereby turn-ing inside-out to invert said top section of said body within the confines of the bottom section of said body; said bottom section of said body being defined by a relatively more rigid and inflexible lower side wall portion; and said upper wall portion having a relatively flexible zone at said one end thereof for defining a primary hinge at which bending of said upper side wall portion will first occur in response to axial pressure on said body to initiate said progressive bending and rolling of said upper side wall portion on itself.

2. In a hypodermic ampoule device including a generally cup-shaped body defined by an upper end wall and a circumferentially extending side wall, a diaphragm peripherally sealed to said body across its mouth to form a lower end wall, and a hypodermic needle secured within said body in position to be thrust through said diaphragm by collapsing of said body; an improved body construction comprising a top section and an integrally connected bottom section of greater diameter than said top section; said top section of said body being defined by an upper side wall portion, said upper side wall portion being relatively flexible for progressively bending and rolling on itself from one end to the opposite end thereof and thereby turning inside-out to invert said top section of said body within the confines of the bottom section of said body; said bottom section of said body being defined by a relatively more rigid and inflexible lower side wall portion; and said upper wall portion having a relatively flexible zone at said one end thereof for defining a primary hinge at which bending of said upper side wall portion will first occur in response to axial pressure on said body to initiate said progressive bending and rolling of said upper side wall portion on itself; and another relatively flexible Zone at said opposite end of the upper side wall portion for defining the secondary hinge to relieve elastic stresses created by progressively bending and rolling said upper side wall portion toward said secondary hinge.

3. In a hypodermic ampoule device including a generally cup-shaped body defined by an upper end Wall and a circumferentially extending side wall, a diaphragm peripherally sealed to said body across its mouth to form a lower end wall, and a hypodermic needle secured within said body in position to be thrust through said diaphragm by collapsing of said body; an improved body construction comprising a top section and an integrally connected bottom section of greater diameter than said top section; said top section of said body being defined by an upper side wall portion, said upper side wall portion being relatively flexible for progressively bending and rolling on itself from one end to the opposite end thereof and thereby turning inside-out to invert said top section of said body within the confines of the bottom section of said body; said bottom section of said body being defined by a relatively more rigid and inflexible lower side wall portion, said top and bottom sections of said body being integrally connected by a wall portion which is relatively thin as compared to the thicknesses of said upper and lower side wall portions, said connecting wall portion defining the final location of a bend in said side wall after said upper side wall portion has been progressively bent and rolled on itself to invert said top section of said body.

4. The structure claimed in claim 3 wherein said connecting wall portion extends radially inwardly of said body and constitutes said primary hinge for initiating said progressive bending and rolling of said upper side wall portion on itself.

5. The structure claimed in claim 4 wherein said body further includes a relatively thin wall portion extending radially inwardly of said body at the top of said upper side wall portion, said relatively thin wall portion defining a secondary hinge for permitting said upper end wall of said body to move relative to said upper side wall portion to relieve elastic stresses tending to reverse the inversion of said top body section.

6. In a hypodermic ampoule device including a generally cup-shaped body defined by an upper end wall and a circumferentially extending side wall, a diaphragm peripherally sealed to said body across its mouth to form a lower end wall, and a hypodermic needle secured within said body in position to be thrust through said diaphragm by collapsing of said body; an improved body construction comprising a top section and an integrally connected bottom section of greater diameter than said top section; said top section of said body being defined by an upper side wall portion, said upper side wall portion being relatively flexible for progressively bending and rolling on itself from one end to the opposite end thereof and thereby turning inside-out to invert said top section of said body within the confines of the bottom section of said body; said bottom section of said body being defined by a relatively more rigid and inflexible lower side wall portion; said upper wall portion having a relatively flexible zone at said one end thereof for defining a primary hinge at which bending of said upper side wall portion will first occur in response to axial pressure on said body to initiate said progressive bending and rolling of said upper side wall portion on itself; and said body portion having a relatively thin Wall portion atthe top of said upper side wall portion for permitting relative movement between said upper end wall of said body and said upper side wall portion and minimizing elastic stresses tending to reverse the inversion of said top section of said body.

7. The structure claimed in claim 6 wherein said relatively thin wall portion at the top of said upper side wall portion extends radially inwardly of said body and constitutes said primary hinge for initiating said progressive bending and rolling of saidupper side wall portion on itself.

8. The structure claimed in claim 7 wherein said body further includes another relatively thin wall portion inte'grally connecting said top and bottom sections of said body, said connecting wall portion defining a secondary hinge at said opposite end of said upper side wall portion for relieving elastic stresses created by progressively bending and rolling of said upper side wall portion toward said opposite end.

9'. In a hypodermic ampoule device including a generally cup-shaped body defined by an upper end wall and a circumferentially extending side wall, a diaphragm peripherally sealed to said body across its mouth to form a lower end wall, and a hypodermic needle secured Within said body in position to be thrust through said diaphragm by collapsing of said body; an improved body construction comprising a top section and an integrally connected bottom section of greater diameter than said top section; said top section of said body being defined by an upper side wall portion having 'a thickness which tapers from a minimum thickness at one-end thereof to a maximum thickness at the opposite end thereof, said upper side wall portion being relatively flexible for progressively bending and rolling on itself from said one end of minimum thickness to said opposite end of maximum thickness and thereby turning inside-out to invert said top section of said body within the confines of said bottom section of said body; said bottom section of said body being defined by a relatively more rigid and inflexible lower side wall portion; and said upper wall portion having a relatively flexible zone at said one end thereof of minimum thickness for defining a primary hinge at which bending in said upper side wall portion will first occur in response to axial pressure on said body to initiate said progressive bending and rolling of said upper side wall portion on itself.

10. The structure claimed in claim 9 wherein said top and bottom sections of said body are integrally connected by a wall portion extending radially inwardly of said body, said connecting wall portion constituting said primary hinge at said one end of said upper side wall portion of minimum thickness.

11. The structure claimed in claim 10 wherein said body includes another radially extending wall portion at the top of said upper side wall portion for defining a secondary hinge to relieve elastic stress created by progressively bending and rolling said upper side wall portion from said one end to said opposite end.

12. In a hypodermic ampoule device including 'a generally cup-shaped body defined by an upper end wall and a circumferentially extending side wall, a diaphragm peripherally sealed to said body across its mouth to form a lower end wall, and a hypodermic needle secured Within said body in position to be thrust through said diaphragm by collapsing of said body; an improved body construction comprising a top section and an integrally connected bottom section of greater diameter than said ltOP section; said top section of said body being defined by an upper side wall portion having a thickness which tapers from a minimum thickness at one end thereof to a maximum thickness at the opposite end thereof, said upper side wall portion being relatively flexible for progressively bending and rolling on itself from said one end of minimum thickness to said opposite end of maximum thickness and thereby turning inside-out to invert said top section of said body within the confines of said bottom section of said body; said bottom section of said body being defined by a relatively more rigid and inflexible lower side wall portion; said body having a relatively flexible wall portion at said one end of said upper side wall portion of minimum thickness for defining a primary hinge at which bending in said upper side wall portion will first occur in response to axial pressure on said body to initiate said progressive bending and rolling of said upper side wall portion of itself; and said upper wall portion including another relatively flexible zone at said opposite end thereof of maximum thickness for defining a secondary hinge to relieve elastic stresses created by progressively bending and rolling said upper side wall portion toward said opposite end.

13. The structure claimed in claim 12 wherein said relatively flexible Wall portion defining said primary hinge extends radially inwardly of said body at the top of said upper side wall portion, and wherein said relatively flexible wall portion defining said secondary hinge integrally connects said top and bottom sections of said body.

14. A generally cup-shaped body particularly suited for use in hypodermic devices of the type described comprising a substantially circular end wall and a circumferentially extending side wall, said side wall having an upper side wall portion defining a top section of said body and a lower side wall portion defining a bottom section of said body, said upper side wall portion being relatively flexible for progressively bending and rolling on itself from one end to the opposite end thereof and thereby turning inside-out to invert said top section of said body within the confines of said bottom section of said body; said lower side wall portion being of greater diameter and relatively more rigid and inflexible than said upper side wall portion, and said upper wall portion having a relatively flexible, circumferentially extending zone at said one end thereof for defining a primary hinge at which bending of said side wall will first occur in response to axial pressure on said body to initiate said bending and rolling of said upper wall portion on itself.

15. The structure claimed in claim 14 wherein said wall portion defining said primary hinge extends radially inwardly of said body.

16. The structure claimed in claim 15 wherein said wall portion defining said primary hinge integrally connects said top and bottom sections of said body.

17. A generally cup-shaped body particularly suited for use in hypodermic devices of the type described comprising a substantially circular end wall and a circumferentially extending side wall, said side wall having an upper side wall portion defining a top section of said body and a lower side wall portion defining a bottom section of said body, said upper side wall portion being relatively flexible for progressively bending and rolling on itself from one end to the opposite end thereof and thereby turning inside-out to invert said top section of said body Within the confines of said bottom section of said body; said lower side Wall portion being of greater diameter and relatively more rigid and inflexible than said upper side wall portion, and said side wfll having a relatively flexible, circumferentially extending zone at said one end thereof for defining a primary hinge at which bending of said side wall will first occur in response to axial pressure on said body to initiate said bending and rolling of said upper wall portion on itself, said portion defining said primary hinge integrally connecting said top and bottom sections of said body and a secondary hinge at said opposite end of said upper side wall portion for relieving elastic stresses created by progressively bending and rolling said upper side wall portion on its said secondary hinge being defined by a circumferential, relatively flexible zone of said body extending radially inwardly of said body at the top of said upper side wall portion.

18. The structure claimed in claim 17 wherein said upper side wall portion tapers in thickness from a minimum thickness at said one end thereof to a maximum thickness at said opposite end thereof, and wherein said lower side wall portion is substantially cylindrical.

19. The structure claimed in claim 17 wherein said upper side wall portion comprises from 40 to 50% of said side wall.

20. A generally cup-shaped body particularly suited for use in hypodermic devices of the type described comprising a substantially circular end wall and a circumferentially extending side wall, said side wall having an upper side wall portion for defining a top section of said body and a lower side wall portion for defining a bottom section of said body, said upper side wall portion being relatively flexible for progressively bending and rolling on itself from the top of said upper side wall portion to the bottom thereof to thereby turn inside-out and invert said top section of said body within the confines of said bottom section of said body, said lower side wall portion being of greater diameter and relatively more rigid and inflexible than said upper side wall portion, and said upper wall portion having a circumferential, relatively flexible zone extending radially inwardly of said body at the top thereof, said circumferential zone defining a primary hinge at which said side wall will first bend in response to axial pressure on said body to initiate said progressive bending and rolling of said upper side wall portion.

21. A generally cup-shaped body particularly suited for use in hypodermic devices of the type described comprising a substantially circular end wall and a circumferentially extending side wall, said side wall having an upper side wall portion for defining a top section of said body and a lower side wall portion for defining a bottom section of said body, said upper side wall portion being relatively flexible for progressively bending and rolling on itself from the top of said upper side wall portion to the bottom thereof to thereby turn inside-out and invert said top section of said body Within the confines of said bottom section of said body, said lower side wall portion being of greater diameter and relatively more rigid and inflexible than said upper side Wall portion, and said body having a circumferential, relatively flexible wall portion extending radially inwardly of said side wall at the top thereof, said circumferential zone defining a primary hinge at which said side wall will first bend in response to axial pressure on said body to initiate said progressive bending and rolling of said upper side wall portion and having another circumferential, relatively flexible zone integrally connecting said top and bottom sections of said body and defining a secondary hinge for relieving elastic stresses created by progressive bending and rolling of said upper side wall portion.

22. The structure claimed in claim 21 wherein said upper side wall portion tapers in thickness from a minimum thickness at said primary hinge to a maximum thickness at said secondary hinge.

23. The structure claimed in claim 21 wherein said upper side wall portion comprises from 40 to 50% of said side wall.

References Cited in the file of this patent UNITED STATES PATENTS 2,667,164 Smith Ian. 26, 1954 2,667,165 Smith Jan. 26, 1954 2,769,443 Dunmire Nov. 6, 1956 2,944,549 Alexander July 12, 1960 

14. A GENERALLY CUP-SHAPED BODY PARTICULARLY SUITED FOR USE IN HYPODERMIC DEVICES OF THE TYPE DESCRIBED COMPRISING A SUBSTANTIALLY CIRCULAR END WALL AND A CIRCUMFERENTIALLY EXTENDING SIDE WALL, SAID SIDE WALL HAVING AN UPPER SIDE WALL PORTION DEFINING A TOP SECTION OF SAID BODY AND A LOWER SIDE WALL PORTION DEFINING A BOTTOM SECTION OF SAID BODY, SAID UPPER SIDE WALL PORTION BEING RELATIVELY FLEXIBLE FOR PROGRESSIVELY BENDING AND ROLLING ON ITSELF FROM ONE END TO THE OPPOSITE END THEREOF AND THEREBY TURNING INSIDE-OUT TO INVERT SAID TOP SECTION OF SAID BODY WITHIN THE CONFINES OF SAID BOTTOM SECTION OF SAID BODY; SAID LOWER SIDE WALL PORTION BEING OF GREATER DIAMETER AND RELATIVELY MORE RIGID AND INFLEXIBLE THAN SAID UPPER SIDE WALL PORTION, AND SAID UPPER WALL PORTION HAVING A RELATIVELY FLEXIBLE, CIRCUMFERENTIALLY EXTENDING ZONE AT SAID ONE END THEREOF FOR DEFINING A PRIMARY HINGE AT WHICH BENDING OF SAID SIDE WALL WILL FIRST OCCUR IN RESPONSE TO AXIAL PRESSURE ON SAID BODY TO INITIATE SAID BENDING AND ROLLING OF SAID UPPER WALL PORTION ON ITSELF. 